Zanidip-rekordati tab p / 10 mg of the film 28 pc


Zanidip-rekordati tab p / 10 mg of the film 28 pc



Active substance:
One film-coated tablet contains: lercanidipine hydrochloride 10 mg or 20 mg ;.
One tablet film coating comprises: lactose monohydrate to 30 mg / 60 mg Cellulose microcrystalline 39 mg / 78 mg Sodium carboxymethyl starch 15.5 mg / 31 mg, povidone K30 4.5 mg / 9 mg magnesium stearate 1 mg / 2 mg; dosage of 10 mg – Opadry Yellow (OY-SR-6497) 3 mg [hypromellose, talc, titanium dioxide (E171), Macrogol 6000, iron oxide yellow dye (E172)]; dosage of 20 mg – Opadry Pink (02F25077) 6 mg [hypromellose, talc, titanium dioxide (E171), Macrogol 6000, iron oxide red dye (E172)].
Dosage 10 mg: Round biconvex tablets, coated light yellow color, with a mark on one side, on the fracture pale yellow color.
Dosage 20 mg: Round biconvex tablets, coated from pink to a dark pink color with the mark on one side, on the fracture pale yellow color.
Product form:
Film-coated tablets 10 mg, 20 mg. At 7, 14, 15, 25, 28, 30 tablets in a blister from a film opaque PVC / aluminum foil.
1, 2, 3, 4, 5, 6, 7 of blisters with instructions for use in a cardboard package.
– Increased sensitivity to lercanidipine, another series of dihydropyridine derivatives or any component of the formulation. – Chronic heart failure decompensation. – Unstable angina pectoris, obstruction of blood vessels originating from the left ventricle of the heart, recent myocardial infarction (within 1 month). – Severe liver function, renal function (glomerular filtration rate of less than 39 ml / min). – simultaneous use of potent inhibitors isoenzyme CYP3A4 (ketoconazole, itraconazole, erythromycin), as well as grapefruit juice, cyclosporine. – Pregnancy and lactation; Use in women of childbearing age not using adequate contraception. – Children under the age of 18 years (effectiveness and safety have been established). – lactase deficiency, lactose intolerance, glucose-galactose malabsortsiya.
Precautions: – Violations of liver function and mild to moderate severity. – sick sinus syndrome (without a pacemaker). – Left ventricular failure and ischemic heart disease. – Chronic heart failure. – Simultaneous treatment with beta-blockers, digoxin.
10 mg
Essential hypertension is mild or moderate severity.
Interaction with other drugs
The drug should not be taken simultaneously with inhibitors of CYP3A4 (Cytochrome P450 isoenzyme liver), such as ketoconazole, itraconazole, erythromycin (lercanidipine increase the concentration in the blood and result in potentiation of the antihypertensive effect).
Contraindicated in concomitant use of lercanidipine with cyclosporin, as it leads to an increase in the content of both substances in the blood plasma. Lercanidipine should not be taken with grapefruit juice, as this leads to inhibition of metabolism of lercanidipine and potentiation of the antihypertensive effect.
Care must be taken at the same time taking with drugs such as terfenadine, astemizole, quinidine and third class antiarrhythmics (e.g., amiodarone).
Simultaneous treatment with anticonvulsant (e.g., phenytoin, carbamazepine) and rifampicin may reduce lercanidipine plasma levels and, therefore, reduce the antihypertensive effect of lercanidipine.
At the same time taking digoxin should be carried out regularly monitored for signs of digoxin toxicity.
The drug with midazolam in old age leads to an increase and decrease the absorption of lercanidipine absortsii speed.
Metoprolol reduces bioavailability of lercanidipine 50%, bioavailability of metoprolol thus remains unchanged. This effect may be due to reduction of hepatic blood flow, which is caused by beta-blockers, however can also be manifested when applied to other drugs of this group.
Cimetidine at 800 mg per day did not lead to significant changes kontsetratsii lercanidipine in blood plasma, however, it requires special care, since at higher doses cimetidine bioavailability of lercanidipine and therefore its antihypertensive effect, can be increased.
While the use of simvastatin, the drug should be taken in the morning and simvastatin – in the evening.
Fluoxetine has no effect on the pharmacokinetics of lercanidipine.
Lercanidipine concurrently with warfarin did not affect the pharmacokinetics of the latter. Lercanidipine may be applied simultaneously with beta-blockers, diuretics, angiotensin-converting enzyme (ACE). Ethanol may enhance the antihypertensive effect lekarnidipina.
Symptoms: peripheral vasodilatation with marked decreases in blood pressure (BP) and reflex tachycardia, increased frequency and duration of attacks of angina, myocardial infarction.
Treatment: symptomatic therapy.
pharmachologic effect
Pharmacological group:
Blocker “slow” calcium channels.
Blocker “slow” calcium channels. Lercanidipine is a racemic mixture of dextro- (R) and levorotatory (S) stereoisomers of 1,4-dihydropyridine derivative, capable of selectively blocking current of calcium ions into cells of the vascular wall, cardiac cells and smooth muscle cells. Mechanism hypotensive action is due to a direct relaxant effect on vascular smooth muscle cells.
It has a prolonged antihypertensive effect. The therapeutic effect is achieved within 5-7 hours after ingestion, and its duration is stored for one day (24 hours). Due to their high selectivity for vascular smooth muscle cells is not the negative inotropic effect.
Lercanidipine is metabolically neutral drug and has no significant impact on the content of lipoproteins and apolipoproteins in the blood serum, and does not alter the lipid profile in hypertensive patients.
– absorption: after ingestion of lercanidipine is absorbed from the gastrointestinal tract (GIT) almost completely. The maximum plasma concentration is reached after 1.5-3 hours and is 3.3 ng / ml and 7.66 ng / ml after receiving the 10 and 20 mg, respectively. – Distribution: Distribution from plasma into tissues and organs is rapid. Communication with plasma proteins exceeds 98%. In patients with renal failure and hepatic content of plasma proteins is reduced, so lercanidipine free fraction can be increased. – Metabolism: metabolized at the “original” through the liver biotransformation by CYP3A4 isoenzyme system to form a variety of metabolites which have no pharmacological activity. – elimination: the intestines and the kidneys occurs after biotransformation. Isolated lercanidipine 2 precipitation phase: early (index value half-life (T1 / 2): 2-5 h) ikonechnuyu (index value T1 / 2: 8.10 hours). The preparation is practically intact not detected in urine and feces.
With repeated use does not accumulates.
Pregnancy and breast-feeding
The drug is contraindicated in pregnancy and during breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
WHO statistics: very often – 1/10 assignments, often – 1/100 appointments, not often – 1/1000 assignments, rarely – 1/10000 appointments, very rarely – less than 1/10000 appointments.
From the nervous system: rarely – drowsiness; rarely – headache, dizziness.
Immune system: very rarely – hypersensitivity.
Cardio-vascular system: rare – tachycardia, palpitations; “Tides” of blood to the facial skin; rarely – angina; very rarely – a faint, marked reduction in blood pressure, chest pain, myocardial infarction.
From the digestive system: rarely – nausea, vomiting, diarrhea, abdominal pain, dyspepsia, rarely – increased activity of “liver” enzymes (reversible); Skin: rare – skin rash.
On the part of the musculoskeletal system: rarely – myalgia.
From the urinary system: rarely – polyuria.
General disorders and local reactions: rarely – peripheral edema, rare – asthenia, fatigue; very rarely – gingival hyperplasia.
special instructions
Caution should be exercised when administered to patients with impaired renal function, coronary heart disease (the risk of increased frequency of angina attacks), in relation to chronic heart failure: need to be compensated before starting the drug. Particular caution should be observed in the initial stages of treatment of patients with mild to moderate severity of liver failure.
Effects on ability to operate machinery and vehicle:
During the period of treatment must be careful when performing tasks that require attention when driving, especially at the beginning of treatment and at higher doses of the drug (the risk of drowsiness, headache and dizziness).
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
The drug-Zanidip® Rekordati appoint 10 mg 1 time per day in the morning, at least 15 minutes before eating, without chewing, with a sufficient amount of water.
The dose may be increased to 20 mg (in case when receiving 10 mg of the expected effect is not achieved). The therapeutic dose is selected gradually increasing the dose to 20 mg is carried out through 2 weeks after the start of treatment.
Use in elderly patients:
No dose adjustment is required, however, while taking the drug requires constant monitoring of patients.
The use in patients with impaired renal or hepatic function:
In the presence of renal or hepatic insufficiency, mild to moderate, usually dose adjustment is required, the initial dose – 10 mg, increasing the dose to 20 mg per day should be done with caution. If the antihypertensive effect is too pronounced, should reduce the dose.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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